Development and Characterization of Gastroretentive Microballoons of Tegoprazan for Antiulcer Activity
Abstract
Peptic ulcer disease remains one of the most prevalent gastrointestinal disorders, primarily caused by excessive gastric acid secretion, Helicobacter pylori infection, and prolonged use of nonsteroidal anti-inflammatory drugs. Although Tegoprazan, a novel potassium-competitive acid blocker (P-CAB), provides rapid and effective suppression of gastric acid secretion, its therapeutic performance may be improved through a gastroretentive drug delivery system that prolongs its residence in the stomach. The present study focuses on the development and characterization of gastroretentive floating microballoons of Tegoprazan to enhance gastric retention, provide sustained drug release, and improve antiulcer efficacy. The optimized formulation demonstrated excellent floating behavior, remaining buoyant for more than 12 hours, with high entrapment efficiency and satisfactory production yield. In vitro drug release studies indicated sustained release of Tegoprazan over an extended period, following controlled-release kinetics and providing a gradual release profile suitable for gastroretentive delivery. The antiulcer potential of the optimized gastroretentive microballoons was evaluated using suitable experimental ulcer models. The formulation exhibited superior gastroprotective activity compared with the conventional Tegoprazan formulation, as evidenced by a significant reduction in ulcer index, enhanced gastric mucosal protection, and prolonged acid suppression. The improved…
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